MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE; INTRA-AORTIC OCCLUSION CATHETER

Model Number ICF100

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

The intraclude device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures.In this case, it was reported that the catheter shaft of the intraclude device ¿degloved¿ from the main catheter body near the hub.An exchange of the device was required and another occlusion method was implemented.In this case, minimal information regarding this event was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful.If new information becomes available or the device is returned for evaluation, a supplemental report will be submitted.

Event Description

It was reported that the sheath of an intra-aortic occlusion catheter began to "deglove" from the main catheter body near the hub.The intra-aortic occlusion catheter was removed and another occlusion method was implemented.No patient injury was noted.No additional details were provided.

Event Description

Edwards received additional information through follow-up.As reported, the issue was observed as the balloon was being pulled back for positioning in the aorta and the team was pulling the slack out of the balloon to migrate it towards the aortic valve.The balloon was partially deflated, but not 100%.The balloon cannot be effectively positioned in the aorta unless it has volume in it, near the occlusion point.

Manufacturer Narrative

Edwards received additional information through follow-up.A supplemental report submitted to include additional information received.Due diligence attempts have been made to obtain the explanted device.However, the device was not returned.An image of the device was reviewed and the report that "the sheath of an intraclude device began to "deglove" from the main catheter body near the hub" was confirmed through the image evaluation.The image showed that the outer shaft layer appeared to be unraveling from the catheter shaft area near the intraclude hub.Per the engineering evaluation, a manufacturing, supplier, design, ifu, and labeling defect were not confirmed.The root cause of the event cannot be determined at this time.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: INTRACLUDE
• Type of Device: INTRA-AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8186821
• MDR Text Key: 131132376
• Report Number: 3008500478-2018-00100
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K132175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61704542
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention